Sandoz, a division of Novartis, reported that its clinical trial comparing the efficacy and the safety of GP2015, its biosimilar candidate to Enbrel (etanercept), met its primary endpoint — effectiveness in people with chronic plaque-type psoriasis — at week 12.
Enbrel, produced by Amgen, treats autoimmune diseases by interfering with tumor necrosis factor (TNF; a soluble inflammatory cytokine) by acting as a TNF inhibitor. It was approved by the U.S. Food and Drug Administration (FDA) to treat rheumatoid arthritis, juvenile rheumatoid arthritis and psoriatic arthritis, plaque psoriasis, and ankylosing spondylitis.
The clinical trial, known as EGALITY (NCT01891864), was a randomized, double-blind, Phase 3 study to demonstrate equivalent efficacy and to compare the safety and immunogenicity of GP2015, the biosimilar etanercept, and Enbrel in 531 Patients with moderate to severe chronic plaque-type psoriasis.
Results from the study were recently presented at the 5th Congress of the Psoriasis International Network (Psoriasis 2016), held in Paris, France.
“The EGALITY study is a landmark in clinical trial design,” Diamant Thaçi, MD, of the Comprehensive Center for Inflammation Medicine, University Medical School Schleswig-Holstein, in Lubeck, Germany, said in a news release. “Data have been collected from over 500 patients in 1 year with multiple treatment switches where a patient receives either the biosimilar etanercept candidate or the originator product on a number of alternate occasions. Data from this study, in addition to analytical, functional and preclinical studies, provide confidence in the comprehensive data package that is the basis for biosimilar medicine approval and use by health care practitioners.”
EGALITY was conducted at 74 dermatology clinics across 11 European countries and South Africa. The primary endpoint was the PASI (Psoriasis Area and Severity Index) 75 response rate (proportion of patients showing at least a 75% improvement in PASI) after the first 12 weeks of treatment. This endpoint was met.
Equivalence between GP2015 and Enbrel in terms of safety and immunogenicity, were confirmed through additional data. The results showed that at Week 12 there was similar incidence of adverse events.
The FDA Arthritis Advisory Committee voted 20-0 in favor of recommending the approval of GP2015 in July for the five indications approved for Enbrel. The recommendation was based on the totality of evidence from Sandoz’s global development program, showing its biosimilar etanercept is highly similar to Enbrel, the company reported in a July press release.
“The EGALITY data, showing our biosimilar etanercept to be bioequivalent to the originator product, is part of the comprehensive data package submitted to the [European Medicines Agency] and FDA,” Malte Peters, head global clinical development, Biopharmaceuticals, Sandoz, said in the recent release.